CClinicalTrials.gg
CompletedNCT05200598Updated Oct 8, 2024

Cardiovascular Risk Predictors in Patients With Psoriasis

An observational study in Psoriasis and Cardiovascular Diseases, sponsored by I.M. Sechenov First Moscow State Medical University. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by I.M. Sechenov First Moscow State Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The investigators are planning to find the right modification of traditionally used risk scores (PASI, DLQI) in patients with psoriasis of different severity to guide the treatment that could potentially extend life, improve cardiovascular outcomes and quality of life in patients with psoriasis and cardiovascular risk factors in a prospective observational study. The traditionally excluded groups of older patients with diabetes mellitus, decreased kidney function and those with potentially worse prognosis are going to be included in the study. As it's known, the number of those patients is on the rise each year and require a close attention of multidisciplinary teams.

02

Conditions studied

  • Psoriasis
  • Cardiovascular Diseases

Keywords

  • psoriasis
  • cardiovascular risk
  • risk factors
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 200 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

I.M. Sechenov First Moscow State Medical University is the lead sponsor of 133 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Considering the different severity of psoriasis, it is possible to divide patients with psoriasis into several subgroups: patients with mild psoriasis; patients with moderate psoriasis; patients with severe psoriasis who are not receiving systemic therapy; patients with severe psoriasis receiving systemic therapy with genetic-engineering biological drugs; patients with psoriatic arthritis receiving genetic-engineering biological drugs.

Inclusion criteria

  • Age over 18 years
  • Written informed consent of the patient to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Age under 18
  • Pregnancy, lactation
  • Very high cardiovascular risk
  • Life-threatening, independently influencing prognosis and disabling diseases,
  • Mental disorders that do not allow to give informed consent or answer questions adequately
  • Refuse of the patient to participate in the study
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • Mild psoriasis
  • Moderate psoriasis
  • Severe psoriasis
  • Patients without psoriasis
06

What researchers measure

Primary outcomes

  1. SCORE2-OP risk (Systematic COronary Risk Evaluation2- Older Person)

    Increased cardiovascular risk over the follow-up period (from low to very high)

    Time frame: 1 year

Secondary outcomes

  1. Overall mortality

    Number of deaths due to all reasons

    Time frame: 1 year

  2. Cardiovascular mortality

    Number of deaths due to cardiovascular reasons

    Time frame: 1 year

  3. Progression of psoriasis (PASI)

    Progression of severity of psoriasis according to PASI (The Psoriasis Area and Severity Index - 0 to 4, none to very severe) score

    Time frame: 1 year

  4. Quality of life (DLQI score)

    Impact on quality of life by DLQI (Dermatology Life Quality Index - 0 to 30, no to extremely large impact) score

    Time frame: 1 year

  5. Hospitalization due to cardiovascular reasons

    Number of patients hospitalized due to cardiovascular reasons

    Time frame: 1 year

07

Study locations

1 site
  • University Clinical Hospital #2
    Moscow, 119991, Russian Federation
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05200598
Lead sponsor
I.M. Sechenov First Moscow State Medical University
Responsible party
Olga Mironova (Associate Professor, I.M. Sechenov First Moscow State Medical University) — Principal investigator
First posted
Jan 21, 2022
Start date
Oct 1, 2021
Primary completion
Sep 1, 2023
Completion
Sep 1, 2024
Last update
Oct 8, 2024

Study contacts

Olga Mironova, MD, PhD
principal investigator · Sechenov University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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